Eighth Edition - R.3 - Human Fertilisation & Embryology Authority

HFEA guidance (cont)
Mandatory requirements (cont)
(6) Condition E is that any embryo or human admixed embryo to be created in vitro is to be used for
the purposes of a project of research which is intended to increase knowledge about–
(a) the disease, disability or medical condition mentioned in sub-paragraph (2) or any
similar disease, disability or medical condition, or
(b)
the treatment of, or care of persons affected by, that disease, disability or medical
condition or any similar disease, disability or medical condition.
(7) Condition F is that there are reasonable grounds for believing that research of comparable
effectiveness cannot be carried out if the only human cells that can be used to bring about the
creation in vitro of embryos or human admixed embryos for use for the purposes of the project
are the human cells of persons who–
(a) have attained the age of 18 years and have capacity to consent to the use of their
human cells to bring about the creation in vitro of an embryo or human admixed
embryo for use for the purposes of the project, or
(b)
have not attained that age but are competent to deal with the issue of consent to such
use of their human cells.
(8) In this paragraph and paragraph 18 references to the person responsible under the licence are to
be read, in a case where an application for a licence is being made, as references to the person
who is to be the person responsible.
(9) In relation to Scotland–
(a) references in sub-paragraphs (3) to (5) to P lacking, or having, capacity to consent are
to be read respectively as references to P being, or not being, incapable (within the
meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving
such consent, and
(b)
sub-paragraph (7) is to be read with the following modifications–
(i)
(ii)
in paragraph (a), for “have capacity to consent” substitute “are not incapable
(within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act
2000) of giving consent”, and
in paragraph (b), for “are competent to deal with the issue of” substitute “have
capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity
(Scotland) Act 1991) to”.
Consulting carers etc. in case of adult lacking capacity
18 (1) This paragraph applies in relation to a person who has attained the age of 18 years (“P”) where
the person responsible under the licence (“R”) wishes to use P’s human cells to bring about the
creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of
research, in a case where P lacks capacity to consent to their use.
(2) R must take reasonable steps to identify a person who–
(a) otherwise than in a professional capacity or for remuneration, is engaged in caring for
P or is interested in P’s welfare, and
(b)
is prepared to be consulted by R under this paragraph of this Schedule.
(3) If R is unable to identify such a person R must nominate a person who–
(a) is prepared to be consulted by R under this paragraph of this Schedule, but
(b)
has no connection with the project.
Human Fertilisation and Embryology Authority
Guidance note | 22. Research and training
Version 1.0